An observational study in Idiopathic Parkinson Disease, sponsored by Supernus Pharmaceuticals, Inc.. Completed at 30 sites in United States. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-07.
Sponsored by Supernus Pharmaceuticals, Inc. · Observational
This is a Phase IV, prospective, observational, post-marketing study designed to obtain additional data on the effect of XADAGO on motor and non-motor symptoms in Parkinson's Disease patients newly prescribed XADAGO.
This Phase IV, multicenter, prospective, observational study to evaluate clinician-reported outcomes and patient-reported outcomes related to motor and non-motor symptoms, health status, quality of life and treatment satisfaction in PD patients who have been newly prescribed XADAGO according to Package Insert indication.
This study also will gather "real world" data from a PD population in the US regarding their overall experience and degree of satisfaction with the use of XADAGO as an add-on treatment to their L-dopa regimen. Treatment experience will be captured using patient self-rating assessments as well as clinician ratings on assessments.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's enrollment of 164 is above the median of 97 across 1,081 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Supernus Pharmaceuticals, Inc. is the lead sponsor of 64 studies on the registry; 6 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Parkinson's Disease patients who have been newly prescribed XADAGO
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
PD patients who have been newly prescribed safinamide (XADAGO) for the treatment of OFF episodes as described in the XADAGO Package Insert
Drug: XADAGO (safinamide)
XADAGO (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes.
Also known as: XADAGO, safinamide
Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
MDS-UPDRS: 4-part assessment of the multiple clinical disabilities of Parkinson's Disease. Part I (13 items; Score 0-52) examines non-motor experiences, Part II (13 items; Score 0-52) examines motor experiences, Part III (33 items; Score 0-132) examines the cardinal motor disabilities and Part IV (6 items; Score 0-24) examines motor complications. Each Part has 0-4 ratings, where 0 (no problems) to 4 (severe problems) and scores for each part are summed to calculate the total score which ranges from 0-260. Higher scores represent worse outcomes for each part and total score.
Time frame: Baseline to Study Day 60
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Scores
PDQ-39 is a patient-reported outcome designed to address aspects of functioning and well-being for those affected by PD. Each of the 39 items is rated using a 5 point Likert scale with 0 for never having difficulties/problems and 4 for always having difficulties/problems. The sum score of the 39 items will be calculated and used for analysis, with scores ranging from 0-156. Higher scores indicate worse outcomes.
Time frame: Baseline to Study Day 60
Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score.
MoCA is a 30-point, 1-page test designed to assess several cognitive domains, including visuospatial abilities (5 points), naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), and orientation to time and place (6 points). The total score ranges from 0 to 30, with higher scores indicating better performances.
Time frame: Baseline to Study Day 60
Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions will be calculated and used for analysis. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction.
Time frame: Study Day 60
Clinical Global Impression of Change (CGI-C)
CGI-C is a 7-point scale depicting a Principal Investigator or certified Health Care Professional designee rating of the patient's overall improvement using a range of responses from a minimum of 1 (very much improved) to a maximum of 7 (very much worse).
Time frame: Study Day 60
Patient Global Impression of Change (PGI-C)
PGI-C is a 7-point scale depicting a patient's rating of overall improvement using a range of responses from 1 (very much improved) to 7 (very much worse).
Time frame: Study Day 60
| Milestone | DA Switchers | MAO-B Switchers | MAO-B Naive |
|---|---|---|---|
| Started | 2 | 34 | 128 |
| Completed | 2 | 30 | 123 |
| Not completed | 0 | 4 | 5 |
| Milestone | DA Switchers | MAO-B Switchers | MAO-B Naive |
|---|---|---|---|
| Started | 1 | 10 | 64 |
| Completed | 0 | 8 | 41 |
| Not completed | 1 | 2 | 23 |
MDS-UPDRS: 4-part assessment of the multiple clinical disabilities of Parkinson's Disease. Part I (13 items; Score 0-52) examines non-motor experiences, Part II (13 items; Score 0-52) examines motor experiences, Part III (33 items; Score 0-132) examines the cardinal motor disabilities and Part IV (6 items; Score 0-24) examines motor complications. Each Part has 0-4 ratings, where 0 (no problems) to 4 (severe problems) and scores for each part are summed to calculate the total score which ranges from 0-260. Higher scores represent worse outcomes for each part and total score.
| score on a scale | DA Switchers | MAO-B Switchers | MAO-B Naive |
|---|---|---|---|
| Part 1 | -5.0 ± 5.66 | -1.0 ± 5.13 | -1.9 ± 6.16 |
| Part 2 | 0.0 ± 2.83 | -2.3 ± 5.40 | -2.6 ± 5.28 |
| Part 3 | 1.5 ± 2.12 | -3.3 ± 7.78 | -4.5 ± 11.10 |
| Part 4 | -0.5 ± 3.54 | -0.3 ± 3.28 | -0.2 ± 3.05 |
PDQ-39 is a patient-reported outcome designed to address aspects of functioning and well-being for those affected by PD. Each of the 39 items is rated using a 5 point Likert scale with 0 for never having difficulties/problems and 4 for always having difficulties/problems. The sum score of the 39 items will be calculated and used for analysis, with scores ranging from 0-156. Higher scores indicate worse outcomes.
| score on a scale | DA Switchers | MAO-B Switchers | MAO-B Naive |
|---|---|---|---|
| Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Scores | -1.8 | 0.5 ± 9.73 | -0.5 ± 9.90 |
MoCA is a 30-point, 1-page test designed to assess several cognitive domains, including visuospatial abilities (5 points), naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), and orientation to time and place (6 points). The total score ranges from 0 to 30, with higher scores indicating better performances.
| score on a scale | DA Switchers | MAO-B Switchers | MAO-B Naive |
|---|---|---|---|
| Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score. | 0.0 ± 1.41 | 0.9 ± 2.41 | 0.4 ± 2.45 |
TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions will be calculated and used for analysis. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction.
| score on a scale | DA Switchers | MAO-B Switchers | MAO-B Naive |
|---|---|---|---|
| Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores | 56.0 | 38.9 ± 7.73 | 41.0 ± 9.81 |
CGI-C is a 7-point scale depicting a Principal Investigator or certified Health Care Professional designee rating of the patient's overall improvement using a range of responses from a minimum of 1 (very much improved) to a maximum of 7 (very much worse).
| Participants | DA Switchers | MAO-B Switchers | MAO-B Naive |
|---|---|---|---|
| Very Much Improved | 0 | 1 | 13 |
| Much Improved | 1 | 7 | 29 |
| Minimally Improved | 0 | 10 | 38 |
| No Change | 1 | 6 | 31 |
| Minimally Worse | 0 | 2 | 7 |
| Much Worse | 0 | 1 | 3 |
| Very Much Worse | 0 | 0 | 0 |
PGI-C is a 7-point scale depicting a patient's rating of overall improvement using a range of responses from 1 (very much improved) to 7 (very much worse).
| Participants | DA Switchers | MAO-B Switchers | MAO-B Naive |
|---|---|---|---|
| Very Much Improved | 0 | 1 | 9 |
| Much Improved | 2 | 3 | 25 |
| Minimally Improved | 0 | 9 | 31 |
| No Change | 0 | 8 | 30 |
| Minimally Worse | 0 | 2 | 2 |
| Much Worse | 0 | 2 | 2 |
| Very Much Worse | 0 | 0 | 1 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DA Switchers | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| MAO-B Switchers | 0/34 (0%) | 2/34 (5.9%) | 8/34 (23.5%) |
| MAO-B Naive | 2/128 (1.6%) | 8/128 (6.3%) | 17/128 (13.3%) |
| Event | DA Switchers | MAO-B Switchers | MAO-B Naive |
|---|---|---|---|
| DysarthriaNervous system disorders | 0/2 | 1/34 | 0/128 |
| Peripheral arterial occlusive diseaseVascular disorders | 0/2 | 1/34 | 0/128 |
| Myocardial infarctionCardiac disorders | 0/2 | 0/34 | 1/128 |
| PalpitationsCardiac disorders | 0/2 | 0/34 | 1/128 |
| Gastric ulcerGastrointestinal disorders | 0/2 | 0/34 | 1/128 |
| Postoperataive ileusGastrointestinal disorders | 0/2 | 0/34 | 1/128 |
| FallInjury, poisoning and procedural complications | 0/2 | 0/34 | 1/128 |
| Pneumothorax traumaticInjury, poisoning and procedural complications | 0/2 | 0/34 | 1/128 |
| Radius fractureInjury, poisoning and procedural complications | 0/2 | 0/34 | 1/128 |
| Rib fractureInjury, poisoning and procedural complications | 0/2 | 0/34 | 1/128 |
| Event | DA Switchers | MAO-B Switchers | MAO-B Naive |
|---|---|---|---|
| TremorNervous system disorders | 1/2 | 1/34 | 2/128 |
| NauseaGastrointestinal disorders | 0/2 | 3/34 | 9/128 |
| FallInjury, poisoning and procedural complications | 0/2 | 2/34 | 11/128 |
| DizzinessNervous system disorders | 0/2 | 2/34 | 4/128 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/2 | 2/34 | 2/128 |
Safety Population: All patients who sign informed consent for the study, complete baseline assessments, and receive at least 1 dose of XADAGO.
| Age, Continuous(years) | DA Switchers | MAO-B | MAO-B Naive | Total |
|---|---|---|---|---|
| Mean | 62.5 ± 6.36 | 65.3 ± 8.28 | 68.1 ± 7.77 | 67.4 ± 7.92 |
| Age, Customized(Participants) | DA Switchers | MAO-B | MAO-B Naive | Total |
|---|---|---|---|---|
| Age 30-65 | 1 | 16 | 39 | 56 |
| Age >= 65 | 1 | 18 | 89 | 108 |
| Sex: Female, Male(Participants) | DA Switchers | MAO-B | MAO-B Naive | Total |
|---|---|---|---|---|
| Female | 0 | 6 | 43 | 49 |
| Male | 2 | 28 | 85 | 115 |
| Ethnicity (NIH/OMB)(Participants) | DA Switchers | MAO-B | MAO-B Naive | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 6 | 6 |
| Not Hispanic or Latino | 2 | 34 | 122 | 158 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | DA Switchers | MAO-B | MAO-B Naive | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 3 | 4 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 | 2 |
| White | 2 | 30 | 121 | 153 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 2 | 2 |
| Height (cm)(cm) | DA Switchers | MAO-B | MAO-B Naive | Total |
|---|---|---|---|---|
| Mean | 179.6 ± 6.51 | 173.1 ± 11.67 | 171.0 ± 11.91 | 171.6 ± 11.83 |
| Weight (kg)(kg) | DA Switchers | MAO-B | MAO-B Naive | Total |
|---|---|---|---|---|
| Mean | 96.2 ± 0.64 | 85.0 ± 16.95 | 88.1 ± 22.60 | 87.6 ± 21.42 |
| BMI (kg/m^2)(kg/m^2) | DA Switchers | MAO-B | MAO-B Naive | Total |
|---|---|---|---|---|
| Mean | 29.9 ± 2.36 | 28.4 ± 5.17 | 30.1 ± 7.05 | 29.7 ± 6.68 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Ran from Nov 2017 to primary completion in Dec 2019, 24 months.
Results were first posted in Feb 2021, 1 year 1 month after primary completion.
Of 59 industry-sponsored observational studies under Parkinson Disease, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's 24 months is below that.
Counting every sponsor, half of 440 studies reached it within 48 months; a quarter within 21 and three quarters within 112.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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